Aveo says partner Astellas will not seek EU nod for kidney cancer drug
May 23 (Reuters) - Aveo Pharmaceuticals Inc said it was informed by its partner Astellas Pharma Inc that the Japanese company would not be seeking marketing approval for their experimental kidney cancer drug in Europe.
Aveo's shares were down about 13 percent in extended trade, after closing at $2.70 on the Nasdaq.
Astellas does not intend to fund any future studies of the drug, tivozanib, in renal cell cancer, Aveo said in a regulatory filing on Thursday. ()
Earlier this month, an advisory panel to the U.S. Food and Drug Administration decided in a 13-1 vote that an additional trial would be needed before tivozanib could be approved for renal cell cancer.
Staff reviewers for the FDA had previously noted that kidney cancer patients on tivozanib did not survive longer when compared with patients on Bayer AG and Onyx Pharmaceuticals' drug, Nexavar.
Following the advisory panel vote, Aveo and Astellas had said they would work with the FDA to address the issues raised by the panel.
Aveo said in Thursday that it was evaluating the effect of the Astellas decision on tivozanib's clinical and regulatory path going forward.
- U.S.'s Kerry expresses regret to India over diplomat case |
- Mega Millions winners in Georgia, California to split $648 million |
- Washington, DC city council raises minimum wage to $11.50/hr in 2016
- China confirms near miss with U.S. ship in South China Sea
- Fed cuts bond buying in first step away from historic stimulus |